CATS April 23, 2008

OFFICE OF RESEARCH ADMINISTRATION

CATSApril 23, 2008

Why OVPRA?

Growth in Activity• Grant Awards $

• 2X in last 10 years


• On pace for over $0.5 Billion for FY 2008

Why OVPRA?

Growth in Activity• Grant Awards $



• On pace for over $0.5 Billion for FY 2008

Sponsored Projects

Why OVPRA?

Growth in Activity• Human subject

protocols• Nearly 2X in last

10 years

• Both IUB and IUPUI

Why OVPRA?

Growth in Activity• Increase in lab and

animal space

• Results in increased demands for• bio-safety• chemical safety• radiation safety• animal care and use

Why OVPRA?

Changing competitive environment

• Decline in funding of research

• 15% decline in purchasing power since end of NIH doubling

Why OVPRA?


• Increase in applications + declining funding

• Falling funding rates

• Success rate for NIH and NSF has fallen from roughly 1 in 3 proposals awarded to 1 in 5

Why OVPRA?

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Reviewed Awarded Success Rate


• Increase in applications + declining funding

• Falling funding rates

• Success rate for NIH and NSF has fallen from roughly 1 in 3 proposals awarded to 1 in 5

NIH Competing Research Project Grant (RPG*) Applications: Trends in Number, Awards and Success Rates

Why OVPRA?

Institutions with Major Compliance Incidents

Stanford UniversitySUNYU. of MinnesotaNorthwestern UC - Lawrence Livermore Johns HopkinsSan Diego StateHarvard U.Virginia CommonwealthU. of Texas Austin U of Ill. Chicago

U. of AlabamaUC IrvineGeorge Washington U.Northeastern U.Florida InternationalU. of Alabama BirminghamMayo ClinicCornellFlorida A&MYaleU. of PennsylvaniaDuke U.U. of Oklahoma

Why OVPRA?

Changing compliance environment• More rules to follow (export controls, conflict of

interest, Privacy Act, etc.)

• Severe penalties for non-compliance

• Increased need for coordinated policies and education

• Inconsistent across components

• IU exposed to high risk

OVPRA Mission Provide exceptional support for Indiana

University’s research community in order to:

Catalyze research productivity Protect from risk

Advisory Committees

Executive Oversight Committee (EOC)

Faculty Advisory Committee (FAC)

Advisory Committees



Provides input from researchers

Membership:Vice Provost, Research, IUB (co-chair)Vice Chancellor, Research IUPUI (co-chair)IUPUI Compliance Committee ChairsIUB Compliance Committee ChairsDirector of REEP

5 research faculty from IUPUI5 research faculty from IUB1 research faculty from regional campusCTSI Director

Advisory Committees



Provides input from administration

Membership:VP for Research Admin. (Chair)Chancellor of IUPUIProvost for IUBVP for Life Sciences (and Dean IUSM)VP for EngagementVP for ITVP and CFOVP and University CounselVP for AdministrationDean of the College of Arts and SciencesFAC Co-Chairs (ex officio)

Provides input from researchers

Membership:Vice Provost, Research, IUB (co-chair)Vice Chancellor, Research, IUPUI (co-chair)IUPUI Compliance Committee ChairsIUB Compliance Committee ChairsDirector of REEP

5 research faculty from IUPUI5 research faculty from IUB1 research faculty from regional campusCTSI Director

New Organization: Benefits Single, university-wide organization

Single point of contact

Preservation of unique campus presence

Enhanced environment for intercampus research collaborations

Status of Reorganization

Personnel Update Consolidated 3 approved positions

Matrix reporting line with OVPA/OVPRA established for Chemical Safety Filled all leadership appointments Moved over 100 employees and their functions to the new organization

Space Very important part of improving coordination IUB – September target date for moving to single location IUPUI – still identifying options for office location

Highlights

Reorganization of Grants Administration

Clinical Trials Office

OVPRA Survey

REEP

Systems and Decision Support Initiatives

Research Compliance Initiatives

Grants Admin Reorg Initiative

IUB & Regional Grant Services

Grant Team 2 NIH, USDE, NEA/NEH, Nat. Parks

Serv.

Grant Team 3Commercial, Non-Profits, Foundations

Grant Team 1NSF, NASA, DOE, NIST

Grant Team 4Federal

Contracts, State, Other

Gov.

Letter of Credit

IUPUI Grant Services


Grant Team 3 Fed Contracts,

State, Other Gov

Grant Team 1NIH & other

Fed.

Reports, Billings, Receivables,

Account Closeout

Audit, Compliance and Effort Reporting

University-wide Operations



Serv.



Grant Team 4Federal


Gov.

Letter of Credit




State, Other Gov


Fed.


Account Closeout




GRANT TEAM COMPOSITIONResearch Consultants

* Assigned specific projects*Proposal review & submission

* Award review & setup* Transaction approvals

* Point of Contact

Contract Officer* Negotiate and Approve Award

Agreements, MTA’s, NDA’s* Draft and Approve Subcontracts

Team Leader* Lead responsibility for all service activity

for team




Serv.



Grant Team 4Federal


Gov.

Letter of Credit




State, Other Gov


Fed.


Account Closeout


University-wide Operations BENEFITS

Single POCGreater familiarity with specific projects and its

needsGreater sponsor expertise, Specialization in staff responsibilities will also

improve efficiency, timeliness, and effectiveness.

Local delivery of grant support services Improved career path will lead to better

retention


Status of Reorganization Job descriptions under review by HR Training is on-going IUPUI Grants Services currently recruiting staff Bakers and Daniels has been contracted to assist with clinical trial

agreements Discussions are underway with IURTC to contract out material transfer

agreements Goal to move to new structure by July 1



Serv.



Grant Team 4Federal


Gov.

Letter of Credit




State, Other Gov


Fed.


Account Closeout



Clinical Trials Office

Centralized coordination of commercial clinical trials

Benefits: Budget review (also for federal clinical trials) Proposal preparation services Separate specialized staff for faster response times Centralized invoice management

July 1 implementation on new clinical trials Roll out over time across departments

OVPRA Satisfaction Survey

• Annual Survey of OVPRA customers - faculty and departmental administrative support

• To be sent out about May 15 and close on June 15

• Survey conducted by IU Center for Survey Research

• Input provided by: • OVPRA directors• OVPRA Faculty Advisory Committee• OVPRA Executive Oversight Committee

OVPRA REEP Initiative

Need for greater research ethics and compliance education NIH heavily encourages Responsible Conduct in Research (RCR) education America Competes Act mandates RCR education for NSF research A comprehensive program of ethics and compliance education does NOT exist at IU A education program can be critical at the time of an audit or inspection

Need for improved research policy structure Many currently outdated, poorly written, and in some cases conflicting Improved feedback and approval process for new policy Improved communication of policies and central repository


REEP Task Force Formed on September 14, 2007 Met from 4 times between October 1 the end of November Co-chaired by Eric Meslin and Jeff White Included faculty from IUB, IUPUI and a regional campus

Key Recommendations from Written Report Strong support for the creation of REEP REEP should be led by individuals with sufficient expertise and skills to

assure credibility REEP should draw on and build on the strengths of distributed expertise

that exists (e.g. Poynter Center, Center for Bioethics, etc.)


REEP Functions Provide Infrastructure

Maintain and classroom and web-based offerings Track educational participation

Research Ethics Education Provide offerings for stewardship of data, collaborative research

strategies, mentoring, authorship practices and intellectual property Provide offerings by leading experts from around the country


REEP Functions (continued)

Research Compliance Education Organize a comprehensive program of compliance education in:

Grant compliance Human subjects Conflicts of interest Export Controls Animal research Privacy Act Billing Compliance

Coordinate compliance committee (IRB, IACUC, etc) education at all campuses


REEP Functions (continued)

Research Policy Coordination & Dissemination Coordinate the creation and on-going maintenance of the complete body of

university policies for research administration.

REEP will ensure that all research policies at Indiana University are current, coherent, and readily available online.

Kuali Research Administration (KRA) Initiative

• Collaborative UITS / OVPRA effort• Community Source effort to build

a Research Admin / Research Compliance IT System

• Brad Wheeler is P.I. on$1.5M from Mellon Foundation Grant

• MIT system (COEUS) to be used as the starting point

• Recently added UC Davis and Colorado State

• Broad and increased participation to include both campuses, currently >20 OVPRA employees

MIT, Boston Medical Center,

Boston University Medical Campus, Brown University, Carnegie Mellon

University, Columbia University,

Dartmouth College, Johns Hopkins,

Purdue University, SUNY, University of

Maryland, University of North

Carolina-Chapel Hill, University of

Rochester, University of

Tennessee, Wayne State University,

Whitehead Institute, Yale

University

Indiana UniversityCornell UniversityMichigan State U.Colorado State U.U. of ArizonaU. of California, DavisHuron Consulting

Other IT System Initiatives

COEUS IRB Implementation Summer 2008 for inter-office module – will

replace unsupported access database Fall 2008 for electronic protocol submission

COI Disclosure form Fall 2008 for e-doc form and routing Working with KRA partners on specifications

Other IT System Initiatives

Grants Admin Tracking Working to merge 3 separate systems 2nd phase will be to provide web based tool to

update on status of proposals and awards

Proposal, Award, and Expenditure Statistics and Reports

OVPRA Web

• May 2008 rollout• Consolidation of 4 websites

• Improved contact information

• Single repository for research policies

• Research Statistics and Reports

• Ethics and Compliance Education Announcements

External Compliance Reviews

Human Research Protection Program (HRPP) Re-Accreditation Upon site visit, received pending re-accreditation, with

only minor issues to address. Full re-accreditation should be granted in June 2008.

NRC Inspections IUB General Inspection - no findings IUB Institutional Controls for sources

New regulations 4 security findings

All findings have been addressed

External Compliance Reviews

NIH Office of Research Integrity Inquiry General survey of COI policy and procedures at IUPUI Requested specific management plans for selected

individuals

Annual A-133 Single Audit (Neil Theobald) University-wide audit of financial aid and sponsored

projects that includes IU’s financial statements as well as its federal awards

General audit of compliance controls No findings

Human Subjects Initiatives

IUB and IUPUI collaborating to: Craft consistent IRB Policies and Procedures Implementation of the Coeus System

IUB Reviewing ‘self-imposed’ policies and procedures

IUB Piloting "The IRB Is In” OHRPP staff hold open hours to pre-review and answer questions Bi-weekly


IUPUI Office Restructuring Goal of improving efficiency in processing research applications Roles have been changed to create greater specialization that will

result in more knowledgeable support and greater efficiency

Use of Western IRB Working on agreement with the Western IRB to provide review of certain

Phase II, III, and IV industry-sponsored research.


ClinicalTrials.gov Working on a process to identify and register trials that must be listed

on the Clinical Trials registry.

HOG IRB Initiative – implemented a central IRB process for statewide HOG projects.

Sponsoring CIC IRB Conference April 2008

Animal Compliance Initiatives

IUB Administrative Changes New attending veterinarian (Dr. Randy Peper) hired by

Sarita with extensive experience New IACUC administrator position created and filled in

January 2008

IUB Response Plan Task Force - formed to create response plan to animal rights groups

Animal Compliance Initiatives

IUPUI Animal Compliance VA began using the IUSM IACUC and animal facilities. Assurance change so faculty from the School of Engineering

may begin using the School’s IACUC and animal facilities. Electronic application by fall 2008.

Conflict of Interest Initiatives

COI Electronic disclosure being developed IUPUI COI Manager hired and Committee appointed Prepared response to recent DHHS COI survey at IUPUI/SOM Drafted and adopted IUPUI Interim Procedures University-wide COI Task Group – to review and streamline policies

and procedures

Questions?

CATS April 23, 2008

Documents

Transcript of CATS April 23, 2008